| Regulatory Authority | Ministry of health and Medical Services |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | NA |
| Medical Device Regulations | Medicinal-Products-Decree-2011 | Click Here |
| Registration Process | Refer part 9 of the regulation |
| Requirement of Authorized Representative | Yes |
| Database | Online Services Portal | Click Here |
| Additional Information | It shall be an offence for any person to sell, import, manufacture or export a device that is not placed on the Registered Devices Register or Provisionally Authorised Devices Register or in contravention of any conditions imposed by the Board. |
| Contact Phone | +679 330 6177 |
| Contact Email | healthfiji.media@gmail.com |
| Contact Address | Amy Street, Toorak, Suva. |